China blames Baxter for heparin deaths

China's government has rejected any responsibility for the ongoing heparin contamination fiasco, denying that any contamination from China  could be the cause of deaths. Instead, the country's State Food and Drug  Administration has blamed the US manufacturer at the center of the  original blood-thinning drug's recall, Baxter International  (Marketletters passim).

According to the SFDA, no heparin-using patients have died outside the  USA and Germany, stating that "more than 10 other countries using  heparin products containing heparin-like products have not reported any  cases of adverse reactions." The adulterating agent was over-sulfated  chondroitin sulfate, which could not be detected by standard tests due  to what both the US Food and Drug Administration and Baxter believe to  be a deliberate scheme. Peter Pitts, director of the USA-based  think-tank, the Center for Medicine in the Public Interest, told the  Marketletter that "there are a lot of issues here that need to be  addressed, most notably criminal opportunism." The same underlying  problems of supply-chain security are present, he argues, in the heparin  case as in previous attempts by criminals to sell substandard or fake  drugs, for example, via parallel trade (Marketletters passim).

Among the accusations levelled against Baxter by the Chinese authorities  are the destruction of drug samples and production records which would  have been needed by the SFDA's investigators, as well as the failure by  the New Jersey-based firm to supply all the materials demanded by the  regulator after a visit to the USA.